Cleared Traditional

K782077 - LANCER ICE CUBE

K782077 is an FDA 510(k) clearance for LANCER ICE CUBE, manufactured by Sherwood Medical Industries. The device is a Class 1 Pathology device with product code JRM cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K782077 · Sherwood Medical Industries · Pathology device
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Apr 1979
Decision
111d
Days
Class 1
Risk

K782077 is an FDA 510(k) clearance for the LANCER ICE CUBE. Classified as Freezer (product code JRM), Class I - General Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on April 3, 1979 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.2050 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sherwood Medical Industries devices

FDA 510(k) Submission Details - K782077

510(k) Number K782077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1978
Decision Date April 03, 1979
Days to Decision 111 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 77d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

JRM Device Classification - Class 1, General Controls

Product Code JRM Freezer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.